# K231910: DermRays Revive

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Lotuxs Technology Co., Ltd.
- Decided: Jan 30, 2024 after 215 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K910422 (1992). 107 ancestors in all.
No later device cites it as a predicate yet.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141425: Elite + Laser System, Cynosure, Inc. (2014) Summary page 5.
- K232117: Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064), Wuhan Lotuxs Technology Co., Ltd. (2023). Cleared while this submission was under review Summary page 5.

## Indications for use
DermRays Revive is intended for hair removal, permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. DermRays Revive is also intended for treatment of wrinkles. DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

Source page: https://510kreport.com/device/K231910
Methodology: https://510kreport.com/methodology